Last Updated on December 31, 2023 by The Health Master
The Central Drugs Standard Control Organisation (CDSCO) has directed all the state drug controllers (DCs) to accept the hard copy of the application to issue registration certificates to trade medical devices, including in vitro diagnostic medical devices, which has been announced by the Union health ministry as an alternative to drug sale license for these devices.
The Drugs Controller General (India), Dr. V. G. Somani, in a notice recently said that the CDSCO has received various representations from the stakeholders, regarding the implementation of the Medical Devices (Fifth Amendment) Rules, 2022, which was notified on September 30, 2022, stating that their application in hard copy is not being accepted by the State Licensing Authority (SLA) for registration.
“Accordingly, all the SLAs are requested to accept the applications in hard copy from such applicants of medical devices and dispose of the application expeditiously on priority and also to ensure uninterrupted access/supply of such medical devices,” said Somani in the notice.
The Medical Devices (Fifth Amendment) Rules, 2022, added a provision for a Registration Certificate to sell, stock, exhibit, or offer for sale or distribute a medical device, including in vitro diagnostic medical devices, as an alternative to a Drugs Sale License, with effect from September 30, 2022.
As per the amended rules, the applicant may apply for a grant of a Registration Certificate in Form MD-41 to the concerned SLA, and the SLA, after satisfying the requirements, shall issue a Registration Certificate in Form MD-42 to sell, stock, exhibit, offer for sale or distribute a medical device, including in vitro diagnostic medical devices, in the country.
In the Medical Devices Rules, 2017, in rule 34, which is on the procedure to apply for a grant of import license where eligibility for application is provided for an authorized agent having a license to manufacture for sale or distribution or wholesale license for sale or distribution, the MoHFW has inserted the provision so that for those who have the registration certificate on Form MD-42, they may also apply for the import license.
Similarly, in Rule 87, which deals with the provisions for the sale of medical devices, a sub-rule has been inserted to mandate that any person who does not hold a license under Sub-Rule (1) and intends to sell medical devices exclusively as referred to in clause (ZB) of Rule 3 (which includes in vitro diagnostic and surgical dressings, among others), shall obtain a registration certificate as provided in these rules.
It mandates that the State Licensing Authority shall appoint licensing authorities for the purpose of issuing registration certificates for such specific areas.
Those who want to sell, stock, exhibit, or offer for sale or distribute a medical device including in vitro diagnostic medical devices, shall make an application in Form MD-41 to the State Licensing Authority for the grant of registration certificate for the same with specific certificates and documents.
It also specifies the conditions of the registration certificate for the sale or distribution of medical devices, which mandates that:
- The registration certificate should be displayed at a prominent place on the premises visible to the public.
- The certificate holder shall provide adequate space and proper storage conditions for the storage of the medical devices.
- The certificate holder shall maintain the requisite temperature and lighting as per the requirements of such medical devices.
- Medical devices shall be purchased only from the importer or licensed manufacturers or registered or licensed entities, among others.
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